K170286 is an FDA 510(k) clearance for the Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by Largan Medical Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on September 18, 2017, 231 days after receiving the submission on January 30, 2017.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K170286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2017 |
| Decision Date | September 18, 2017 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPL - Lenses, Soft Contact, Daily Wear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |